Superbug Lurks as Physicians Await Device-Cleaning Guidance

Meticulously cleaning duodenoscopes linked to several cases of antibiotic-resistant CRE infection "should reduce the risk of transmitting infection, but may not entirely eliminate it," says the FDA.

In the latest superbug outbreak, which is associated with contaminated duodenoscopes used in a gastroenterology procedure, the only consensus is that the device is hard to clean.

Hundreds of patients have been exposed to antibiotic-resistant CRE, (carbapenem-resistant Enterobacteriaceae) because of the contaminated scopes, but the FDA has not halted their sale, nor has it suggested that physicians stop using them.

In an update issued last week, however, the FDA said there may not be a way to totally rid the device of bacteria. "Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it," says the FDA's safety communication.

Duodenoscopes are primarily used in an ERCP, (endoscopic retrograde cholangiopancreatography) a procedure used to treat bile duct and pancreatic problems. The FDA estimates that 500,000 ERCPs are performed annually in the U.S.

But its recent guidance puts physicians in a precarious position: They don't have complete confidence in the disinfection instructions from the three primary manufacturers of these scopes, but they can't stop seeing patients who need the procedure that uses the scopes in question.

"There's no consensus as to what is the best reprocessing, sterilization, cleaning procedure, so everybody is essentially going by their own protocol," says Yousif A-Rahim, MD, PhD, chief medical officer for Covenant Surgical Partners, the Nashville-based owner and operator of 28 ambulatory surgery centers.

Rahim is also a practicing gastroenterologist who performs ERCPs at the West Roxbury Campus of Boston's VA Healthcare System and at the Pali Momi Medical Center in Hawaii. He says the superbug contamination on the scopes caught him by surprise.

"I am very shocked," he says. "People have been doing this procedure [ERCP] for probably well over 30 years. It exposed a potential fault in the scope, but it's interesting that it took 30 years for that [superbug] to be exposed."

A Design-Related Problem
The dominant manufacturer of the duodenoscope used in ERCPs is Olympus (yes, the same Olympus name on your camera). The company issued a two-page patient safety information letter on February 19th, notifying physicians to pay special attention to an elevator on the scope that has small crevices that need to be cleaned manually. The letter from Olympus pre-dates the FDA's statement that the scope might not be able to be completely free of infection.

"The infection in question has really only been reported in the duodenum scope because it has this elevator, which is connected to a channel… and apparently nothing can really get into that channel to clean it," says A-Rahim.

Although none of Covenant's ASCs perform ERCPs, A-Rahim says the heightened awareness of infection risk was enough to prompt the centers to randomly test its scopes for infection.

"We implemented this a few weeks ago," he says. We were getting cultures from all scopes and looking to see that our processes are adequate."

The results from the random sample?

"All negative," he says. "Our facilities are completely bug-free because we don't do those procedures, and we follow the recommended reprocessing and disinfection procedures. But we know this [CRE outbreak] happened despite those protocols."

Without clear guidance on the best way to disinfect the duodenoscopes, A-Rahim says he knows colleagues who are "gassing" them, a procedure that takes much longer and impacts patient volume.

"The scope processing used to take 30 minutes, now people are basically gassing the scopes (with bleach or hydrogen sulfide) for somewhere between 24–48 hours," he says. "Some of my colleagues won't do [the procedures] anymore because of the liability. I could do seven procedures in the morning; there's no way I could do seven procedures now."

Two patients have died from the CRE superbug linked to duodenoscopes used in ERCP procedures and five other patients have been infected. Those patients were treated at Ronald Reagan UCLA Medical Center in Los Angeles, but CRE has also been found at Cedars-Sinai Medical Center, also in Los Angeles.

According to the FDA, 75 medical device reports were filed between January 2013 and December 2014 relating to infections as a result of the duodenum. The reports indicate 135 affected patients, and now Bloomberg News is reporting the FDA's struggle to get Olympus to improve its disinfection guidelines for the scope.

A-Rahim says the various gastroenterological societies, the FDA, and the manufacturers are working to come up with a consensus on protocol.

"We don't know the best method to sterilize the scopes. The manufacturer doesn't know. We don't know, but it's taken on a contagion-like pitch."